Under the direction of the COO, the Director/Manager of Product Development/Engineering will provide cross-functional project management support for early development projects by coordinating resources necessary to monitor the projects in a timely and efficient manner. The Director/Manager of Product Development/Engineering will plan and coordinate a wide range of development activities in the areas of Formulations, Regulatory, QA, Clinical, Engineering, and Supply Chain. The Director/Manager of Product Development/Engineering will assist in the development and implementation of effective plans for projects including leading resolution efforts for all project-related risks and issues. In addition, the Director/Manager of Product Development/Engineering will provide management oversight while tracking, controlling and reporting on the progress of the project plans.
Key Duties And Responsibilites:

Support project meetings
Develop and maintain plans for projects
Makes follow-up contacts with applicable parties in order to monitor projects to successful outcomes within a timeframe that guarantees the company a competitive edge.
Track, control and report progress against plan
Identify, track and lead resolution efforts for all project-related risks
Plan and coordinate development activities on aggressive fast tracks and projects with more relaxed timelines, with the goal of keeping all projects moving forward.

Supervisory Responsibilites:
Provides direction to the Engineering staff to assure that all development projects and manufacturing processes conform to applicable standards and documented requirements.
Travel Requirements:
20
Minimum Requirements And Qualifications:
The requirements listed below are representative of the knowledge, skill, and or ability required for this position.

Bachelors degree in life sciences, engineering or other similar discipline (an advanced degree is preferred).
6 years experience in the medical device industry
3 years of experience managing cross functional device development projects
Proficiency with MS Excel, MS Project, Visio and PowerPoint

Additional Preferred Qualifications:

Experience in a start-up or small company environment
Six Sigma certification/training
13485 Quality Systems